Data / Medical devices / United States / GF Health Products, Inc
GF Health Products, Inc: FDA-registered device maker in Atlanta, GA, United States, 2 510(k) clearances
GF Health Products, Inc is registered with the FDA (registration 2428983) in Atlanta, GA, United States. It lists 15 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 31, 1993. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2428983
- FEI number
- 2427360
- Address
- 1 Graham Field Way, Atlanta, GA, United States, 30340
- Owner or operator
- GF Health Products, Inc. (2428983)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 7, 1995
- Registered through
- 2026
- Brand names listed
- 3789 Bite Block, 740 Series, Everest & Jennings, Gendron, Gendron Reclining Chair, Gendron Shower Commode, Grafco, HSS500, Hausted Chairs; Electric All Purpose and Surgical and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 31, 1993 | K930411 | UNIVERSAL WHEELCHAIR | IOR | Substantially Equivalent | Everest & Jennings, Inc. | accessdata.fda.gov |
| February 17, 1989 | K890567 | BITE BLOCK #59430 | JXL | Substantially Equivalent | Medi-Source, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 24, 2021 | 87606 | Class II | Terminated | Drop Arm Versamode" | The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. | accessdata.fda.gov |
| September 14, 2009 | 53301 | Not yet classified | Terminated | John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube. | Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications. | accessdata.fda.gov |
| April 2, 2007 | 37747 | Not yet classified | Terminated | Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360. | The caster bolt stem/screw may loosen over time causing the wheel to come off. | accessdata.fda.gov |
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Updated March 31, 1993. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.